A Profile: The Medicines Patent Pool Initiative

Ellen 't Hoen, head of UNITAID's Medicines Patent Pool Initiative, speaks during a press conference at the International AIDS Conference in Vienna.

During IAS 2010 in Vienna, UNITAID’s Ellen ‘t Hoen gave a plenary presentation on the organization’s new Medicines Patent Pool Initiative, a project that began to take shape in 2008. Hoen leads the program, which aims to lower the cost of HIV/AIDS, malaria and tuberculosis drugs by working with pharmaceutical companies to allow generic production of their patented medicines in resource-limited settings.

According to the UNITAID website, treating a patient for one year with today’s recommended first-line AIDS treatment costs between $151 and $1,033 – in part because certain products are patented in some countries. This is an almost two to 13-fold increase from the price of the most affordable and widely used older regimen.

The cost today of providing Triamune, a fixed-dose combination (FDC) of several pharmaceutical compounds patented by different entities into a single pill, including D4T, is about $67 dollars per patient per year, Hoen said. “The guidelines today say we have actually improved treatments available and we should try to replace in particular the D4T and get other treatments, preferably in fixed-dose combinations, out to people,” Hoen said at a press conference. The often severe side effects associated with treatment including D4T have pushed many advocates to press for the use of less-toxic, albeit more expensive medicines in the treatment of patients with HIV/AIDS.

“The cost of those drugs is much higher. We’re looking at seven to 14 times higher, even in the best case scenarios,” Hoen said.

That’s where the patent pool comes in.

While the typical patent term is about 20 years per product, through making licenses available to generic manufacturers, “you can shorten that time and actually make licenses available from day one,” Hoen said. Add on one to two years for generic manufacturers to get the drug into development, and that could shave 18 years off of the typical patent length, resulting in increased access to less-expensive versions of high-quality drugs.

UNITAID has committed $4 million over the course of 2010 to fund the patent project. That makes the next step solidifying commitments from pharma. So far, drugmakers Merck, Gilead and Tibotec are showing “considerable interest” in participating in the pool, according to Hoen.

Stay tuned to ScienceSpeaks for updates on the patent pool and potential participants.

In related news, the latest issue of The Journal of the American Medical Association includes an article by Charles Holmes, MD and colleagues evaluating the uptake of generic, and in some cases FDA-tentatively approved antiretrovirals (ARV) amongPEPFAR-supported programs in Guyana, Haiti, Vietnam, and 13countries in Africa. The team also looks at changes of ARV use and costs over time in the article, entitled “Use of Generic Antiretroviral Agents and Cost Savings in PEPFAR Treatment Programs.”